ADMINSTER: Assessment of Digital Consultations on Clinical Impact and Efficiency

Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05413447
Collaborator
(none)
150
2
22

Study Details

Study Description

Brief Summary

Healthcare workers have a high workload as compared to other sectors and this burden is projected to increase due to an aging society. Additional workload is also expected by implementation of recommendations from new European Society of Cardiology guidelines. This is important, because most patients are not treated with optimal medical treatment according to the guidelines. This study aims to evaluate the impact of digital consultations (DC) on efficiency and clinical impact in heart failure (HF) patients.

A randomized controlled trial on DC will be performed comprising of digital information sharing and video consultation (VC). Patients can store current medication use, receive information about their disease via an E-Learning, record blood pressures at home, and view laboratory results and recommended medications. Included patients will be randomly assigned to perform DC or standard care.

This randomized controlled trial is expected to be the first to demonstrate greater adherence of new guidelines and show reduction of workload due to time savings in VHD and HF patients.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: Digital consult
N/A

Detailed Description

Introduction: Healthcare workers have a high workload as compared to other sectors and this burden is projected to increase due to an aging society. Additional workload is also expected by implementation of recommendations from new European Society of Cardiology guidelines. This is important, because most patients are not treated with optimal medical treatment according to the guidelines. This study aims to evaluate the impact of digital consultations (DC) on efficiency and clinical impact in heart failure (HF) patients.

Hypothesis: It is hypothesized that healthcare workers will save time due to DC on data entry in electronic patient records and rather spend time on implementation of guidelines for optimal treatment of patients. Patients will save time on travelling to the hospital and are expected to have a more satisfactory contact by DC instead of telephone consultation.

Methods: A randomized controlled trial on DC will be performed comprising of digital information sharing and video consultation (VC). Patients can store current medication use, receive information about their disease via an E-Learning, record blood pressures at home, and view laboratory results and recommended medications. Included patients will be randomly assigned to perform DC or standard care.

Endpoints: Guideline adherence, care consumption and patient satisfaction will be evaluated at baseline and at 10 weeks after inclusion for the group with DC and standard care. In total 150 patients will be enrolled.

Expected results: Pilot studies on DC report promising results on feasibility and time efficiency. This randomized controlled trial is expected to be the first to demonstrate greater adherence of new guidelines and show reduction of workload due to time savings in VHD and HF patients.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized controlled trialRandomized controlled trial
Masking:
None (Open Label)
Masking Description:
Masking is not feasable as patients and healthcare workers will know whether they are receiving normal care or digital care. Outcome measures are determined beforehand. Only a significance check will be performed.
Primary Purpose:
Supportive Care
Official Title:
Assessment of Digital Consultations on Clinical Impact and Efficiency Using a RCT (ADMINISTER) Trial
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Nov 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients receiving digital consultations

Consultations for HFrEF will be prepared digitally using the Mychart patient portal, a digital elearning and questionnaires. The VC takes place via Teams (Microsoft, Redmond, United States of America). The cardiologist can choose to see a patient physically if deemed appropriate, but the consult will by default be planned as a VC.

Combination Product: Digital consult
Consultations will be prepared digitally using the Mychart patient portal, an elearning and questionnaires. The consultation takes place via Teams.

No Intervention: Patients receiving physical consults

A group of patients receiving no intervention.

Outcome Measures

Primary Outcome Measures

  1. Adherence to periodic screening of iron insufficiency [Prior to, and up to 1 month after the consultation]

    It is checked whether periodic (once a year) screening of iron deficiency is performed. For patients with periodic screening for iron deficiency a score of 1 is allocated. Other patients will receive a score of 0. Significant differences between groups will be assessed at both timepoints.

  2. Adherence to the treatment with ACE/ARNI according to the guidelines [Prior to, and up to 1 month after the consultation]

    The treatment with ACE/ARNI in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.

  3. Adherence to the treatment with betablockers according to the guidelines [Prior to, and up to 1 month after the consultation]

    The treatment with betablockers in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.

  4. Adherence to the treatment with MRA according to the guidelines [Prior to, and up to 1 month after the consultation]

    The treatment with MRA in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.

  5. Adherence to the treatment with SGLT2i according to the guidelines [Prior to, and up to 1 month after the consultation]

    The treatment with SGLT2i in accordance to the guideline is measured at baseline and within 4 weeks after the consult. The received dose is divided by the target dose per timepoint. The score will range between a maximum of 1 (corresponding with a treatment according to the guidelines) and a minimum of 0 (corresponding with not administering the medicine). Significant differences between the two groups are determined at both timepoints.

Secondary Outcome Measures

  1. Patient satisfaction [Prior to, and up to 1 month after the consultation]

    Patient satisfaction measured with the Net Promotor Score. This is a score in which the patient is asked to give a value between 1 and 10 indicating the likelihood that he/she will recommend the care given at the AUMC to other patients (1 equals unlikely and 10 likely).

  2. Difference in summary score of Kansas city cardiomyopathy questionnaire [Prior to, and up to 1 month after the consultation]

    Worsening of experienced HF, assessed with the "Kansas city cardiomyopathy questionnaire". This will lead to a summary score indicating the severity of the experienced heart failure. This score will range from 0 indicating a bad outcome of the questionnaire to 100 indicating a good outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • HFrEF

  • Severe secondary mitral valve insufficiency with complaints

Exclusion Criteria:
  • Patients not in possession of any attributes to perform the consults digitally

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Schuuring, Principle investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT05413447
Other Study ID Numbers:
  • 123456567
First Posted:
Jun 10, 2022
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mark Schuuring, Principle investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2022